Ornilatex concentrate solution for infusion 500mg/ml 10ml ampoules, 10pcs

Composition

Composition per 1 ampoule:  Active substance: Ornithine aspartate – 5,0 GH Auxiliary substance: water for injection up to 10 ml

Pharmacological action

Reduces the increased concentration of ammonia in the body, in particular, in liver diseases. The effect of the drug is associated with its participation in the Ornithine cycle of Krebs urea formation (formation of urea from ammonia). Ornithine acts as a catalyst for the enzymes carbamoyl phosphate synthetase and Ornithine carbamoyl transferase, and is also the basis for urea synthesis. In addition, the drug activates the Ornithine cycle of urea formation, which also helps to reduce the level of ammonia. Promotes the production of insulin and somatotropic hormone. Improves protein metabolism in diseases requiring parenteral nutrition. Pharmacokinetics. In vivo, it forms two active metabolites: aspartate and Ornithine, which have a short half-life of 0.3-0.4 hours, and are excreted by the kidneys through the urea cycle. A small portion of aspartate is excreted unchanged by the kidneys.

Indications

• acute and chronic liver diseases accompanied by hyperammonemia;
• hepatic encephalopathy, including as part of the complex therapy of impaired consciousness (precoma and coma);
• as a corrective supplement to parenteral nutrition preparations in patients with protein deficiency.

Contraindications

• severe renal insufficiency (serum creatinine >3 mg / 1 dl);
• hypersensitivity to the components of the drug;
• breast-feeding period;
• children under 18 years of age.

Side effects

Very rare (less than 0.01%): – nausea, vomiting; – allergic reactions.

Interaction

Not detected. The drug solution should not be mixed with other medications. For dilution, use only the solutions specified in the instructions (0.9% sodium chloride solution,5% dextrose (glucose) solution or Ringer’s solution).

How to take, course of use and dosage

Intravenous (IV) drip. The contents of the ampoules are mixed with 500 ml of an infusion solution (0.9% sodium chloride solution,5% dextrose (glucose) solution or Ringer’s solution). Adults have an average therapeutic dose of 20 g of Ornithine per day. With hepatic encephalopathy (depending on the severity of the condition), up to 40 g of Ornithine is administered intravenously per day. It is recommended to dissolve no more than 30 g of Ornithine in 500 ml of infusion solution. The maximum infusion rate is 5 g of Ornithine per hour. The duration of therapy with the drug is determined in each case individually, based on the pathology and severity of the patient’s condition. In severe hepatic impairment, strict monitoring of the patient’s condition and correction of the drug use rate is necessary to prevent the development of nausea and vomiting. DetiNet of data on the use of the drug in pediatric practice.

Overdose

Symptoms:  increased severity of dose-dependent side effects. Treatment:  the drug should be discontinued and symptomatic treatment should be performed.

Special instructions

When the drug is administered in high doses, the concentration of urea in blood plasma and urine should be monitored. In case of severe hepatic impairment, the rate of infusion solution use should be reduced in accordance with the patient’s condition in order to prevent nausea or vomiting. Influence on the ability to drive vehicles and mechanisms. It does not affect the ability to drive a vehicle or potentially dangerous mechanisms.

Storage conditions

In a dark place, at a temperature not exceeding 25 °C. Keep out of reach of children.

Shelf life

2 years

Active ingredient

Ornithine

Conditions of release from pharmacies

By prescription

Description

For adults as directed by your doctor

Indications

Liver damage